Kornimate/medical-research-clean huggingface dataset:
dermal cryotherapy in patients undergoing abdominoplasty

Conditions: Skin Laxity

Summary: a prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

this study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the dermal cooling system within 180 days before the planned surgery. exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.

Eligibility criteria:
inclusion criteria: 1. male or female subjects \> 18 years of age. 2. subjects eligible, consented, and scheduled for abdominoplasty. 3. subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period. 4. subject has read and signed a written informed consent form. - exclusion criteria: 1. subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery). 2. subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, enbrel). 3. subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, reynaud's disease). 4. subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline) 5. artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period. 6. subject is unable or unwilling to comply with the study requirements. 7. subject has any dermatological conditions or scars (other than stretch marks) within the area of planned abdominoplasty excision that may interfere with the ability to obtain test sites for treatment or evaluation. 8. subject has a history of abnormal wound healing or abnormal scarring. 9. subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 10. patient is pregnant or intending to become pregnant within the next 6 months. 11. patient is lactating or has been lactating in the past 9 months. 12. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the patient.
assessment of dried blood spot thyroglobulin and urinary iodine concentration in pregnant women

Conditions: Iodine Deficiency; Pregnancy Related

Summary: to avoid iodine deficiency and its consequences in pregnant women and their offspring, women should reach a sufficient iodine intake long before conception. to monitor iodine status, median urinary iodine concentration (uic) is widely used in pregnant women (pw). thyroglobulin (tg) us another marker used to assess iodine status . in this study, urine samples as well as dried blood spots will be collected to measure uic and tg (as well as other hormones to define thyroid function) in pw. the results shall be used to reassess the threshold which defines iodine status in pw according to uic.


Eligibility criteria:
inclusion criteria: 1. generally healthy 2. no major medical illness, no thyroid disease, and taking no chronic medication 3. no use of iodine containing dietary supplements 4. no use of iodine-containing x-ray /ct contrast agent or iodine containing medication within the last year 5. aged between 18 and 44 at enrollment 6. singleton pregnancy 7. non-smoking 8. residence at study site since 12 months or longer
melatonin treatment after laparoscopic cholecystectomy

Conditions: Postoperative Complications; Fatigue; Dyssomnias

Summary: circadian disturbances occur after surgery. a double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.

postoperative fatigue and sleep disturbances occur after minimally invasive surgery. the pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. it is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. we set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.

Eligibility criteria:
inclusion criteria: * operation for gall bladder disease * age over 18 years exclusion criteria: * known preoperative sleep disturbance * anticoagulant therapy * psychiatric disease * lack of written informed consent * treatment with hypnotics within one week prior to surgery

Keywords: melatonin, fatigue, sleep quality, circadian, postoperative postoperative fatigue postoperative sleep disturbance general wellbeing
the use of indocyanine green to visualize blood flow to the gastrojejunostomy during bariatric surgery.

Conditions: Ulcer, Gastric; Obesity, Morbid

Summary: this is an interventional pilot study aimed to evaluate the use of nif imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during roux-en-y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.

the purpose of this study is to examine intraoperative usefulness of near-infrared light fluorescence imaging with a contrast agent called indocyanine green to improve visualization of blood flow to a surgical connection between the small intestine and stomach (gastrojejunostomy) in patients undergoing gastric bypass surgery. icg will be given prior to and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion score will be given by the surgeon and assistant during the surgery. patients will be recruited before the laparoscopic roux-en-y gastric bypass surgery and the study data will be collected prospectively through standard bariatric follow up visits up to 2 years. a mid-term analysis of the procedure and patient outcomes will be performed for quality assurance purposes when half the study patients have undergone intraoperative icg use. the icg will be not given if a patient is allergic to sodium iodide or has a history of allergy to iodides because of the risk of a severe allergic reaction. participants will be assigned an identifying number to protect confidentiality. descriptive univariate and multivariate statistical analysis will be performed on all patients satisfying the study's inclusion criteria.

Eligibility criteria:
inclusion criteria: * capacity to provide informed consent. * over the age of 18. * eligible for bariatric surgery in ontario and deemed an appropriate candidate for rygb surgery by the bariatric program. * commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss. * treatment of marginal ulcer with the revisional surgery. exclusion criteria: * not willing to participate in study * contraindication to, or not planned to undergo rygb * known allergy to indocyanine green or sodium iodide * is participant pregnant or planning to get pregnant in next two years * ongoing substance abuse or active smoking * bleeding diathesis or coagulopathy * unwilling to take ppi medication post operatively
improving therapeutic patient education for atopic dermatitis: evaluation of a parent handbook

Conditions: Dermatitis, Atopic

Summary: the objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (ad) in improving clinical outcomes for pediatric patients with ad and their parents. the handbook was developed by an interdisciplinary team of healthcare providers to facilitate therapeutic patient education as a routine component of care for pediatric patients with atopic dermatitis (ad). patient education is an important element of practice management guidelines for ad, particularly given complex treatment plans and high rates of non-adherence in this population. parents of children with ad will be randomized into either the handbook arm (handbook provided as an adjunct to standard ad management with a healthcare provider at boston children's hospital) or the control arm (standard management alone). participants will complete study measures at two time points: baseline (prior to a clinic visit appointment for ad care at boston children's hospital), and 3-month follow-up. data will be analyzed for change on study outcome measures (ad symptoms, ad severity, quality of life) and satisfaction with the handbook.


Eligibility criteria:
inclusion criteria: * diagnosis of atopic dermatitis * scheduled for clinic visit for evaluation/management of atopic dermatitis at boston children's hospital exclusion criteria: * parent is spanish speaking * parent is foster parent
physiotherapy in hereditary spastic paraplegia

Conditions: Hereditary Spastic Paraplegia

Summary: goal of this study is to develop and evaluate a physiotherapy concept that is focused on bilateral leg spasticity and aims to reduce spastic gait disturbance and to improve mobility in patients suffering from hsp.

this is a randomized single-center parallel study with a control group design. a blinded block randomization in groups of four was performed in equal parts toward the treatment (tpc) or the control (regular standard-of-care) group using randomization.com. group assignment was kept in a closed envelope which was opened by the participant at the end of the baseline visit. therefore both, the movement disorder specialist as well as the physiotherapist, were blinded to the randomization result for the baseline assessment up to the beginning of the first physiotherapy training session. therapeutic effects were evaluated at follow-up visits after 12 weeks (first visit, short-term effect) and after 26 weeks (second visit, long-term effect) comparing standard-of care with the tpc. clinical evaluation is stated in detail below. primary outcome assessment of this study was the change between baseline and follow-up assessment in treatment to control group in the spastic paraplegia rating scale (sprs) score as a validated measure of disease severity (see reference). secondary outcome assessment was the change in walking distance in the three-minute-walking test (3mw). further exploratory outcome assessments were evaluated as effect sizes as specified below.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hereditary spastic paraplegia * manifest spastic gait disturbance * remaining walking ability of at least 100m in three minutes, * no botulinum toxin treatment during the entire study and three months prior to study inclusion * no functional electronic stimulation during the study period. exclusion criteria: * see above
therapeutic efficacy study of pyrimethamine/sulfdoxine (fansidar®) for the treatment of uncomplicated falciparum malaria in the peruvian amazon

Conditions: Malaria, Vivax; Malaria, Falciparum

Summary: the purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (fansidar®) for the treatment of uncomplicated falciparum malaria in the peruvian amazon. reports in the mid 1990s indicated that fansidar was failing to cure patients with confirmed falciparum malaria. the study design was based on accepted who parasitological and clinical outcomes to determine the overall efficacy of fansider and inform the peruvian national malaria control authorities as to the continued wisdom of recommending fansidar as first line treatment for uncomplicated falciparum malaria in the peruvian amazon.


Eligibility criteria:
inclusion criteria: * pf monoinfection with asexual forms * parasite density of greater than 500 per mcl and less than 200 parasites per oil immersion field (minsa quantification of "4 plus") * age \> 6 months * temperature greater than 38c (101f) * available and willing to return for follow-up exclusion criteria: * presence of any of the following "danger" signs or symptoms suggestive of severe malaria * not able to drink or breastfeed * repeated vomiting (unable to keep anything down) * convulsions during present illness * lethargic or unconscious state * unable to sit or stand up * respiratory distress * jaundice (observation) or dark urine (by history) * severe anemia (hemoglobin \< 5 g/dl) * hypotension (systolic bp \< 80 mm hg in adults and \< 50 mm hg in children under the age of 5 * presence of another significant illness or chronic disease * known pregnancy (by history) * history of hypersensitivity to medication used in the test

Keywords: peru sulfadoxine-pyrimethamine drug resistance
circulating tumor cell capture for early diagnosis and postoperative tumor recurrence monitoring of liver cancer

Conditions: Circulating Tumor Cell

Summary: through the screening of ctcs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of ctcs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of ctcs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.

1. screen patients with suspected liver cancer long-term exposure to liver cancer risk factors (hepatitis b carriers, past history of schistosomiasis, long-term diet of aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected. 2. monitor the number of ctcs in the blood of patients with liver cancer before and after surgery imaging examinations show that liver space is occupied by patients with suspected liver cancer. use ctcbiopsy® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery the number of ctcs in peripheral blood. 3. to evaluate the clinical application significance of ctcs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of ctcs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new the liver cancer prediction model improves the prognosis of liver cancer patients.

Eligibility criteria:
inclusion criteria: 1. primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer; 2. age 18-75 years old; 3. asa (risk of anesthesia) score i-ii; 4. the ecog score is 0-1; exclusion criteria: 1. in addition to hepatocellular carcinoma, patients diagnosed with other types of tumors; 2. patients with extrahepatic or lymphatic metastasis; 3. patients who still have serious complications 4 weeks after surgery; 4. patients who cannot provide informed consent;

Keywords: circulating tumor cells, hepatocellular carcinoma
esketamine combined with prf of drg for acute/subacute zoster-associated pain

Conditions: Herpes Zoster

Summary: to assess the 1-month effects and safety of esketamine - prf -standardized drug treatment against prf -standardized drug treatment acute/subacute zoster-associated pain (zap) patients.

this study aims to determine whether the addition of esketamine to prf - standardized drug treatment can improve 1 - month pain control and safety profiles in acute/subacute zap patients. the findings may help optimize current treatment strategies for refractory zap patients.

Eligibility criteria:
inclusion criteria: 1. ages more than 18 years; 2. patients with onset of herpes zoster (hz) rash less than 90 days; 3. hz affected the spinal nerves (cervical/thoracic/lumbar nerve); 4. having an average pain score of at least 4 on a numeric rating scale (nrs, 0 = no pain, 10= worst possible pain)； 5. planned to perform ct-guided prf treatment of the dorsal root ganglion(drg). exclusion criteria: 1. obstructive sleep apnoea syndrome; 2. those who receive other more invasive treatments, such as radiofrequency thermocoagulation (rft) of drg. 3. a history of systemic immune diseases, organ transplantation, or cancers; 4. a history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder; 5. a history of schizophrenia, epilepsy, or myasthenia gravis, delirium; 6. comorbid hyperthyroidism or phaeochromocytoma; 7. recent history of drug abuse; 8. having contraindications to esketamine; 9. communication difficulties. 10. women who are preparing for pregnancy, in the pregnancy or lactation period.

Keywords: herpes zoster neuralgia esketamine
evaluation of the sub epidermal moisture a device for the screening of pressure ulcer (reliasem)

Conditions: Preventive Care

Summary: the device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. the sub epidermal moister(sem) scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician

the device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. the sub epidermal moister(sem) scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician. the study "reliasem" will study hospitalized patients with high risk of pressure injurieswith the next conditions: for each patient 14 mesures: 6 on the sacrum, 4 on the right heel and 4 on the left heel. this set of measure will be realized 2 timesby 4 different evaluator. to will have been trained in the use of the sem scanner where as the other will be novice. the main objective of this study is to determine on a risk population the intra- and inter-examiner reliability of the sem scanner

Eligibility criteria:
inclusion criteria: * aged over 18 * taken the full-hospital care in physical and rehabilitation medicine * patient affiliated with a social security scheme * in the case of curatorship, patient have read the patient information document and given his consent free and informed, in the presence of his/her curator * in the case of guardianship, legal representative have to had read the legal representative information document for major placed under legal protection (under guardianship) and given his consent free and informed for the person for whom he is responsible (if the patient is agree), exclusion criteria: * patient who objected his opposition during the exam * patient who have one or more presure ulcer on at list one of the measuring area * patient who has had a lower limb amputation * pregnant, post natal period or breastfeeding women, * person deprived of liberty by judicial or administrative decision
mobilizing hispanics with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among hispanics with knee osteoarthritis (oa). hispanic patients with knee oa paired with a chosen family member/close friend will be recruited for study participation. a pilot randomized controlled trial will be conducted. study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about oa, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about oa. study participants will fill out a survey before the start of the study and 3 months after.

feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.

Eligibility criteria:
inclusion criteria: * hispanic/latino ethnicity * ≥ 50 years of age * access to a device with internet connection * chronic, frequent knee pain (national health and nutrition examination survey criteria) * meet american college of rheumatology criteria for knee oa womac pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions exclusion criteria: * unknown or non-hispanic ethnicity * condition that prevents ability to provide consent * illness with a life expectancy \<12 months * history of arthroplasty or prosthetic leg * inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout) * condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)

Keywords: hispanic exercise
upper extremity muscle strength, balance and functional skills in dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with dmd.


Eligibility criteria:
inclusion criteria: * diagnosed with dmd by a child neurologist and confirmed by genetic test results, * were at level 1-4 according to brooke lower extremity functional classification (able to ambulate independently and get up from a chair) * had cooperation with the researchers exclusion criteria: * had undergone a surgical operation in the last 6 months * had contractures that would affect functional activities

Keywords: duchenne muscular dystrophy upper extremity balance functional skills